Since 2011 and the first ISO 17025 and ISO 17020 accreditations, in January 2020 HeX can boast Europe’s most extensive cleanroom testing scope, with almost 40 specialized ISO 17025-accredited tests.
As the HeX Group renews its accreditations in January 2020 for a further 5 years, the loss of confidence in the competent authority BELAC is growing, leading HeX to announce publicly on June 20, 2020, the voluntary relinquishment of its accreditations, effective January 1, 2021.
GMP/BPF recognition
Ever since HeX started out, the ISO 17000 standards have formed the foundations of its management system, in particular ISO 17025 for testing, sampling and calibration laboratories.
After a decade of accreditations, HeX withdrew from the system and has confirmed its compliance with ISO 17025 across a scope of 40 tests.
The construction of the new laboratory at HeX LAB in October 2020, with its fully connected state-of-the-art facilities and technology, in terms of matrices associated with drugs, gave another boost to the HeX Group’s journey towards GMP/BPF standards for the pharmaceutical industry.
HeX: an ongoing commitment to quality
Since January 2021, HeX has been working hard to fulfil the euGMP requirements in order to welcome an inspection from the Federal Agency for Medicines and Health Products (Belgium) in June 2021.
8 October 2021
HeX GROUP
is officially recognised for its compliance with GMP
and in particular for quality control for drugs products.
This recognition fits in with HeX’s commitment to guaranteeing high quality for its clients. In addition, these GMP requirements also fit in with the continuity expected by HeX clients, whether they are in industry, biotech or hospital services, when it comes to fulfilling the same GMP requirements as they have to meet.
Scope GMP
– Sterility testing – European Pharmacopoeia, chapter 2.6.1
– Microbiological control of non-sterile products: Microbial enumeration tests – European Pharmacopoeia, chapter 2.6.12
– Microbiological control of non-sterile products: Testing for specified micro-organisms – European Pharmacopoeia, chapter 2.6.13
– Testing for bacterial endotoxins – European Pharmacopoeia, chapter 2.6.14
Thank you everybody!
HeX GROUP and all of its employees are proud to continue in their quest for quality
whilst also building real partnerships with its clients, with a view to achieving a win-win relationship for everybody.
Would you like more information about our GMP approval and/or our quality management system?
